Pharmacy Prior Authorization Criteria

Recorlev (levoketoconazole) - PA, NF

Indications for Prior Authorization

Recorlev (levoketoconazole)

• For diagnosis of Cushing's Syndrome
  Indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing's syndrome for whom surgery is not an option or has not been curative.

  Limitations of Use: RECORLEV is not approved for the treatment of fungal infections. The safety and effectiveness of RECORLEV for the treatment of fungal infections have not been established

Criteria

Recorlev

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of Cushing's syndrome demonstrated by urinary free cortisol (UFC) increase of 50% from baseline [3]
AND
• Patient is being treated for endogenous hypercortisolemia (e.g., pituitary adenoma, ectopic tumor, adrenal adenoma)[1,2]
AND
• One of the following:
• Patient is not a candidate for surgery
OR
• Surgery has not been curative
AND
• Trial and failure for a minimum of 90 days, or intolerance to oral ketoconazole [A]
AND
• Prescribed by or in consultation with an endocrinologist

Recorlev

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy as demonstrated by ONE of the following:
• Normalization of urinary free cortisol (UFC) [1]
• At least a 50% decrease in UFC levels [3]
AND
• Trial and failure for a minimum of 90 days, or intolerance to oral ketoconazole [A]

Recorlev

Non Formulary

Length of Approval: 6 Month(s)

• Submission of medical records (e.g., chart notes) confirming diagnosis of Cushing's syndrome demonstrated by urinary free cortisol (UFC) increase of 50% from baseline [3]
AND
• Patient is being treated for endogenous hypercortisolemia (e.g., pituitary adenoma, ectopic tumor, adrenal adenoma)[1,2]
AND
• One of the following:
• Patient is not a candidate for surgery
OR
• Surgery has not been curative
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure for a minimum of 90 days, or intolerance to oral ketoconazole [A]
AND
• Prescribed by or in consultation with an endocrinologist

P & T Revisions

2024-02-14, 2023-11-30, 2023-02-22, 2022-06-15, 2022-03-17

References

1. Recorlev [prescribing information]. Chicago, IL: Xeris Pharmaceuticals, Inc.; June 2023.
2. Guaraldi F, Salvatori R. Cushing Syndrome: Maybe Not So Uncommon of an Endocrine Disease. The Journal of the American Board of Family Medicine. 2012;25(2):199-208.
3. Per clinical consult with endocrinologist, February 11, 2022.

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End Notes

1. Per feedback from consultant, determining efficacy of ketoconazole therapy is difficult to determine as multiple dose adjustments often need to be made depending on patient's response. Consultant recommends failure to respond to therapy be defined as requiring more than 3-4 dose adjustments or no response after 4 months. [3]

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Revision History

• 2024-02-14: 2024 UM Annual Review. Added embedded step of t/f of oral ketoconazole to reauth criteria. Background updates
• 2023-11-30: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-02-22: 2023 UM Annual Review. No changes
• 2022-06-15: Update Guideline
• 2022-03-17: New program for Recorlev

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